1. Field of the Invention:
The present invention relates to an apparatus and method for performing a percutaneous or non-dissection procedure to establish a passage or entry into a body cavity or viscus.
2. Description of the Prior Art
A number of devices have been advanced for non-dissection establishment of passages into a body cavity or hollow viscus, particularly for tracheostomies. Such devices are normally preferable to dissection procedures, which require considerable surgical skills in that many blood vessels are involved which tend to bleed profusely during a dissection procedure.
U.S. Pat. No. 3,511,243 (Toye) discloses a method and apparatus which utilizes a dilator to which a flexible leader is separably attached. First, a hollow needle is inserted into the trachea, and the leader is then passed through the needle and into the trachea, following which the needle is withdrawn. An inner guide telescoped within an outer guide is attached to the leader and both are forced into the trachea along the path defined by the leader. The inner guide is then withdrawn, removing the leader with it. A breathing tube is then inserted through the outer guide into the trachea, following which the outer guide is withdrawn, leaving the breathing tube in position. The method involves a precise sequence of steps, and the sequence of use of the various components requires appreciable training.
U.S. Pat. No. 4,364,391 (Toye) discloses a related but somewhat less involved procedure. A slotted outer needle and an inner needle telescoped within the outer needle are inserted into the trachea by means of a syringe attached to the inner needle. The syringe and attached inner needle are withdrawn, leaving the slotted outer needle in place. A leader is fed through the needle and into the trachea. The leader is attached to a dilator which is telescopably received within an outer trachea tube. In a simultaneous action, the needle is withdrawn from the trachea, and the leader is laterally stripped away from the needle through its slot, leaving the leader in the trachea. Using the leader as a guide, the dilator and trachea tube are forced into the trachea, following which the dilator and its attached leader are withdrawn, leaving the trachea tube in position. Use of the slotted outer needle allows fixed attachment of the leader to the dilator, as compared to the arrangement of U.S. Pat. No. 3,511,423. However, the procedure nevertheless requires significant training of personnel in the precise steps to be followed.
U.S. Pat. No. 4,471,778 (Toye) is related to and is an outgrowth of the procedures set forth in the above-identified '243 and '391 patents. The method and apparatus of this patent eliminates one of the two needles of the prior patent, instead using a single splittable needle which receives the dilator leader. More particularly, a syringe is used to insert the splittable needle, following which a leader is inserted through the splittable needle into the trachea. The leader is attached to a dilator which is laterally disposed through an opening in the side of a breathing tube, and then out the end of the breathing tube. After insertion of the leader, the needle is split and removed. Next, the dilator is thrust into the trachea, carrying the breathing tube with it. Finally, the dilator and attached leader are laterally removed from the side opening in the breathing tube, leaving the breathing tube in position within the trachea. The use of the splittable needle and the lateral entry of the dilator into a side opening in the breathing tube simplified the procedures of the previously mentioned patents, but certain complexities in procedure remained.
The present invention is an extension of the foregoing inventions, and was developed to reduce the number of component parts of the apparatus and to simplify the method of use.